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Algenex and Global DX Announce Positive Evaluation of Herdscreen® ASFV Antibody Test for African Swine Fever

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Algenex and Global DX Announce Positive Evaluation of Herdscreen® ASFV Antibody Test for African Swine Fever

Analysis of this new rapid test at the European Union Reference Laboratory for African swine fever (CISA-INIA) shows 100% specificity and higher sensitivity than a commercial ELISA test for the detection of specific antibodies in field and experimental samples from infected animals

This new pen-side diagnostic test for African Swine Fever will be commercially available in 2020. Discussions are ongoing with distributors in various territories

Madrid (Spain) and Stirling (UK), July 21, 2020.- Algenex SL (or the "Company"), a private biotechnology company delivering disruptive technologies for recombinant biologics production, and Global DX Ltd., a company dedicated to improving the quality of animal care by facilitating accurate diagnosis for veterinarians worldwide, today announce results of a positive evaluation of the Herdscreen® ASFV Antibody Test.

The Herdscreen® ASFV Test is a point-of-care rapid diagnostic test to identify pigs who have been exposed to the African Swine Fever Virus (ASFV). It uses a carefully selected ASFV protein, which confers high sensitivity to the new test. The recombinant version of this antigen is produced through CrisBio® technology, Algenex' proprietary and patent protected Baculovirus vector-mediated expression platform that harnesses the power of insects to act as natural single-use bioreactors. The test is simple and easy to use and does not require complex technical training or sophisticated equipment.

Analysis conducted at Centro de Investigación en Sanidad Animal (CISA-INIA) as a European Union Reference laboratory for African swine fever (EURL-ASF), in a validation study using 282 serum and blood samples from ASFV positive animals, showed the test to have analytical specificity of 100% and analytical sensitivity of 86%. Importantly, the sensitivity was greater than that shown by a commercial ELISA test. The Herdscreen® ASFV Test has been considered appropriate as a front-line diagnostic test for African Swine Fever (ASF) in field conditions for both serum and blood samples.

"Rapid detection of infected animals, as in any other infectious disease, is essential to avoid and mitigate the global dissemination of this dangerous virus, and helps sanitary authorities take rapid decisions when an infection is determined," said Dr. José Escribano, founder and CSO of Algenex and one of the world leading experts on ASF.

 "Our collaboration with Algenex, combining their expertise in protein expression and deep understanding of ASFV and our experience in developing best-in-class rapid diagnostic tests has resulted in a much needed diagnostic product for the simple and accurate detection of ASFV-infected pigs. We look forward to bringing this rapid test to the market as soon as possible," said Andrew Shepherd, Founder and CEO of Global DX.

African Swine Fever is a severe viral disease for which there is currently no available vaccine. It affects domestic pigs and wild boars and causes high mortality, approaching 100% in less than 10 days in acute cases. This represents possibly the most serious threat that the global veterinary industry has had to face in the last decades. Serological diagnostic tests, like the Herdscreen® ASFV Test, are essential tools for the eradication of ASF, as the detection of chronic, subacute or subclinical infected animals is extremely important to stop the dissemination of the virus in the domestic pig and wild boar populations.

For further information, please contact:

Algenex contact                                                                                                 Global DX contact
Claudia Jiménez                                                                                                 Andrew Shepherd
General Manager                                                                                                Founder & CEO
T: +34 91 452 4941                                                                                           T: +44 1259 230830
cjimenez@algenex.com                                                                                      andrew.shepherd@globaldx.com

About Algenex

Algenex is a private biotechnology company developing disruptive baculovirus-based technologies for the production of recombinant biologics. Algenex´ first two platforms, TopBac® and CrisBio®, are based on baculovirus-based expression systems and have demonstrated their capacity to transform recombinant protein production through a process that provides almost unlimited and immediate scalability of manufacturing, production flexibility, simplicity and versatility while being extremely cost efficient.

To date, Algenex' work has centered mainly on the development and production of veterinary vaccines, with > 200 molecules successfully produced in collaboration with public and private partners, including multiple international pharmaceutical companies. The first dossier for a veterinary vaccine produced in CrisBio® is currently being reviewed by EMA.

Algenex has now expanded the application of its proprietary and patented technologies into human health in order to fully exploit the potential of its platforms. 

For more information, please visit http://www.algenex.com

About Global DX

Global DX Ltd is a private veterinary diagnostics company developing and producing high quality and innovative diagnostic solutions specialising in Rapid Test technologies. On the basis of more than 70 years of experience in the In Vitro Diagnostics industry, the company is aiming to improve the quality of animal care by facilitating accurate diagnosis for veterinarians worldwide. Building on a range of Rapid Tests for Companion Animals (Petscreen®) and Livestock Animals (Herdscreen®) Global DX is applying Rapid Test technologies and novel test solutions for important diseases of worldwide importance.
                              
For more information, please visit http://www.globaldx.com

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